E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Anesthetic failure of the inferior alveolar nerve block in mandibular molars with irreversible pulpitis |
Fracaso de la anestesia del bloqueo del nervio dentario inferior en molares mandibulares con pulpitis irreversible aguda |
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E.1.1.1 | Medical condition in easily understood language |
Failure of the anesthetic technique when it is applied in mandibular molars with acute inflammation of the dental pulp |
Fracaso de la anestesia cuando ésta es aplicada en molares mandibulares con inflamación aguda de la pulpa dental |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10054799 |
E.1.2 | Term | Perioperative analgesia |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10037464 |
E.1.2 | Term | Pulpitis dental |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038286 |
E.1.2 | Term | Regional nerve block |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002325 |
E.1.2 | Term | Anesthesia local |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To increase the anesthetic efficacy of the inferior alveolar nerve block with 4% articaine with 1:100000 epinephrine by the preoperative administration of 50 mg of submucous tramadol in patients with irreversible pulpitis in mandibular molars |
Aumentar la eficacia anestésica de la articaína 4% 1:100000 de epinefrina mediante la aplicación preoperatoria de 50mg de tramadol en el bloqueo del nervio dentario inferior en molares mandibulares con pulpitis irreversible aguda. |
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E.2.2 | Secondary objectives of the trial |
Enhance the effect of the local anesthetic by the administration of tramadol
Assessement of the postoperative analgesic effect of tramadol
To provide a greater intra and preoperative analgesia with the local administration of tramadol |
Potenciar el efecto del anestésico local con la administración del tramadol.
Valoración de la duración del efecto analgésico postoperatorio del tramadol.
Proporcionar mayor analgesia intra y preoperatoria con la administración local del medicamento. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
ASA I patients between 18 and 64 years old with acute irreversible pulpitis in a mandibular molar. The diagnosis of acute irreversible pulpitis would be given by the following symptoms: - spontaneous pain, - exaggerated and prolonged sensitivity to cold, - sensitivity to touch, pulp exposure and / or - pain with postural changes. |
pacientes ASA I de entre 18 y 64 años de edad con pulpitis irreversible aguda en un molar mandibular. El diagnóstico de la pulpitis irreversible aguda vendría dado por los siguientes síntomas: - dolor espontáneo, - sensibilidad exagerada y prolongada con el frío, - sensibilidad a la palpación, exposición pulpar y/o - dolor con cambios posturales. |
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E.4 | Principal exclusion criteria |
- Hypersensitivity to any of the drugs used in the study, - Pregnancy or lactation - Use of analgesics in the last 24 hours - Asthma patients - Patients with renal or hepatic insufficiency - Patients taking anticonvulsants - Patients taking MAOI's - Patients taking barbiturates, benzodiazepines, phenothiazines or other tranquilizers drugs, sedatives or hypnotics - Drug dependent patients - Patients with hypothyroidism - Patients taking digoxin. |
- Hipersensibilidad a alguno de los medicamentos usados en el estudio, - Embarazo o lactancia - Uso de analgésicos en las últimas 24 horas - Pacientes con asma - Pacientes con insuficiencia renal o hepática - Pacientes en tratamiento con anticonvulsivantes - Pacientes en tratamiento con IMAO?s - Pacientes en tratamiento con barbitúricos, benzodiacepinas, fenotiacinas u otros fármacos tranquilizantes, sedantes o hipnóticos - Pacientes drogodependientes - Pacientes con hipotiroidismo - Pacientes en tratamiento con digoxina. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point in this trial is to increase the success of the inferior alveolar nerve block in patients with irreversible pulpitis of a mandibular molar in at least a 30% |
Aumentar el éxito del bloqueo del nervio dentario inferior en pacientes con pulpitis irreversible aguda en un molar mandibular en, al menos, un 30% |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
It's assumed that data for the primary end point could be analyzed after six months from the begining of the trial |
Los datos para obtener los resultados de la variable principal se podrán analizar a los seis meses de haber comenzado el estudio |
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E.5.2 | Secondary end point(s) |
- To eliminate the need to take postoperative medication
- To increase the suration of the local anesthetic solution. |
- Eliminar la necesidad de tomar medicación postoperatoria por parte del paciente.
- Aumentar la duración del efecto del anestésico local. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The same as for the primary end point |
Lo mismo que para la variable principal |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |